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48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg,50mg,100mg,200mg,400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg SPH3127 tablet-Dose 1 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet. |
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| 50 mg SPH3127 tablet-Dose 2 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet. |
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| 100 mg SPH3127 tablet-Dose 3 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet. |
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| 200 mg SPH3127 tablet-Dose 4 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet. |
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| 400 mg SPH3127 tablet-Dose 5 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 | Drug | Drug: SPH3127 Tablet Drug: Placebo Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG] | adverse events, laboratory data, vital signs, and ECG et al. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter 1 [Cmax] | Peak plasma concentration (Cmax) | 2 days |
| Assessment of PD parameter 1 [Inhibition of Renion Activity (%)] | Inhibition of Renion Activity (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HONG MIAO | Shanghai Pharmaceuticals Holding Co., Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The capital medical university affiliated Beijing anzhen hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653620 | Derived | Jing S, Xu R, Yang K, Liu W, Zhang L, Ke Y, Xia G, Lin Y. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Clin Ther. 2021 Apr;43(4):735.e1-735.e14. doi: 10.1016/j.clinthera.2021.01.025. Epub 2021 Feb 27. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
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| 800 mg SPH3127 tablet-Dose 6 | Experimental | 6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet. |
|
| 2 days |
| Assessment of PD parameter 2 [Blood pressure (mmHg)] | Blood pressure (mmHg) | 2 days |
| Assessment of PK parameter 2 [tmax] | time to peak plasma concentration (tmax) | 2 days |
| Assessment of PK parameter 3 [AUC] | Area under the plasma concentration versus time curve (AUC) | 2 days |